Auto Adjusting Dynamic AFO for Foot and Ankle Injuries
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new type of ankle-foot brace, the Variable Stiffness AFO, designed for individuals recovering from lower-leg injuries. The goal is to enhance support for movement by adjusting the brace's stiffness, increasing comfort and effectiveness in daily activities. Participants will use the brace both in a lab and at home to evaluate its performance during walking and running. The trial seeks individuals who regularly use an ankle-foot orthosis and can run for at least one minute without stopping. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve mobility solutions for many.
What prior data suggests that this Variable Stiffness AFO is safe for users?
Research has shown that ankle foot orthoses (AFOs) can improve walking. One study found that participants walked more normally and had better ankle control when using an AFO. Another study discovered that different AFO designs can compensate for weak ankle muscles, leading to improved movement.
The variable stiffness AFO under testing adjusts to activity, potentially increasing comfort and support. This new design could also help prevent joint problems over time. Current research suggests that AFOs are generally well-received, with many users experiencing improved walking patterns and stability. Participants should report any discomfort or issues to the study team.12345Why are researchers excited about this trial?
Researchers are excited about the Auto Adjusting Dynamic AFO because it offers a personalized approach to managing foot and ankle injuries. Unlike traditional ankle-foot orthoses (AFOs) which have fixed stiffness, this new device features variable stiffness, allowing it to adjust to different levels of activity and terrain. This adaptability not only promises greater comfort and mobility for users but also potentially enhances rehabilitation by providing optimal support tailored to individual needs. Additionally, the device can be set to an adjustment-capable mode or a "locked" mode, offering flexibility and a closer mimicry of natural movement compared to standard, static AFOs.
What evidence suggests that this Variable Stiffness AFO is effective for foot and ankle injuries?
Research has shown that ankle-foot orthoses (AFOs) with adjustable stiffness can improve walking for people with lower-leg injuries. Studies have found that these devices can increase walking speed and step length, particularly for stroke recovery patients. By adjusting stiffness levels, they reduce ankle strain, enhance balance, and lower the risk of long-term joint issues. Early results suggest these AFOs can adapt support based on user activity, enhancing effectiveness. In this trial, participants will test the Variable Stiffness AFO in various settings, including treadmill walking in a laboratory and home use over several weeks. Overall, evidence supports that variable stiffness AFOs can aid in regaining mobility and improving function after lower-leg surgery.678910
Who Is on the Research Team?
Joan E Sanders, PhD
Principal Investigator
University of Washington
Are You a Good Fit for This Trial?
This trial is for individuals who use an offloading Ankle-Foot Orthosis (AFO) at least 20 hours a week, have had major lower-limb surgery and are at least six months post-operation. Participants must be able to run for one minute continuously and have been prescribed an AFO with a strut length of at least 200 mm.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
In-lab Testing
Participants carry out a protocol comprised of treadmill walking and other tests in a laboratory setting while wearing the Dynamic AFO device
Home Use
Participants take the Dynamic AFO home and wear the device for up to 4 weeks in either an adjustment-capable mode or a 'locked' mode
Follow-up
Participants are monitored for safety and effectiveness after treatment, including completing questionnaires on fatigue, pain, and satisfaction
What Are the Treatments Tested in This Trial?
Interventions
- Variable Stiffness AFO
Trial Overview
The study is testing a new type of dynamic brace called Variable Stiffness AFO, designed to adjust its stiffness based on the user's activity level. The goal is to improve mobility while protecting the injury site and nearby joints from long-term damage.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will be asked to take the Dynamic AFO home and wear the device for up to 4 weeks. The device will be set in either an adjustment-capable mode, or a "locked" mode that functions similar to their own orthotic--the order in which they are tested will be randomized.
Participants will carry out a protocol comprised of treadmill walking in a laboratory setting while wearing the Dynamic AFO device.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
United States Department of Defense
Collaborator
Citations
The variable stiffness orthosis: customizable mechanics for ...
Using the VSO, the participant with sciatic nerve injury had reduced foot drop, increased total ankle moments, reduced biological ankle moments, reduced toe ...
Effects of stiffness-optimized ankle–foot orthoses on gait ...
Our preliminary results indicate that stiffness-optimized AFOs may improve anterior-posterior margins of stability, while they do not improve other stability ...
How Does Ankle-foot Orthosis Stiffness Affect Gait in Patients ...
An increase in AFO compliance resulted in 20% to 26% less knee flexion relative to the nominal (p = 0.003) and stiff (p = 0.001) conditions, respectively.
The Effects of AFO Heel Height and Stiffness on Gait
The proposed study evaluates the effect of ankle foot orthosis (AFO) heel height and stiffness on the forces and motion of the lower limb during over-ground ...
Effectiveness of an ankle–foot orthosis on walking in ...
AFO improves walking speed, cadence, step length, and stride length, particularly in patients with stroke. AFO is considered beneficial in ...
Effects of carbon versus plastic ankle foot orthoses on gait ...
Therefore, such changes when using an AFO lead to a more normalized gait, with greater stability during walking, better control of ankle plantar ...
The Effects of AFO Heel Height and Stiffness on Gait
The proposed study evaluates the effect of ankle foot orthosis (AFO) heel height and stiffness on the forces and motion of the lower limb ...
Application of Carbon Fiber Ankle Foot Orthoses to ...
Introduction: There is evidence that ankle foot orthoses (AFO) designs can impact gait outcomes for patients with neurologic dysfunction.
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utsouthwestern.elsevierpure.com
utsouthwestern.elsevierpure.com/en/publications/comparison-of-five-different-methodologies-for-evaluating-anklefoComparison of five different methodologies for evaluating ...
Results: There were significant differences in measured AFO stiffnesses between test methods. Specifically, the BRUCE and HW methods measured lower stiffness ...
10.
braceworks.ca
braceworks.ca/2017/03/10/devices/lower-limbs/afo/afo-stiffness-can-help-optimize-patient-function/AFO stiffness can help optimize patient function
Her research suggests AFO stiffness can replace lost ankle muscle function and provide functional gains.
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